Evidence map›Paper›PMID 40932100›Full record

Trial reportJournal of the American Heart Association2025

CHOSEN: A Randomized Controlled Feasibility Trial.

Craig J Smith, Andrew Brand, Zoe Hoare, Eileen Jones, Catherine Davidson, Wendy Westoby, Ian Clements, Fiona Sandom, Clare Gross, Anu Thomas and 8 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of the American Heart Association, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Craig J SmithDivision of Cardiovascular Sciences University of Manchester Manchester UK.ORCID 0000-0002-9078-9919
Andrew BrandNorth Wales Organisation for Randomised Trials in Health (NWORTH) Clinical Trials Unit, Bangor University Bangor UK.ORCID 0000-0002-6942-0404
Zoe HoareNorth Wales Organisation for Randomised Trials in Health (NWORTH) Clinical Trials Unit, Bangor University Bangor UK.ORCID 0000-0003-1803-5482
Eileen JonesDivision of Cardiovascular Sciences University of Manchester Manchester UK.
Catherine DavidsonSchool of Nursing and Midwifery University of Central Lancashire Preston UK.ORCID 0000-0003-2183-4031
Wendy WestobyStroke Patient and Public Involvement Group Geoffrey Jefferson Brain Research Centre, Salford Royal Hospital Salford UK.
Ian ClementsStroke Patient and Public Involvement Group Geoffrey Jefferson Brain Research Centre, Salford Royal Hospital Salford UK.
Fiona SandomAll Wales Faculty for Dental Professionals Bangor UK.
Clare GrossOral and Maxillofacial Surgery Salford Royal Hospital Salford UK.
Anu ThomasStroke Unit, Department of Clinical Neurosciences Royal Preston Hospital Preston UK.
Lucy TalbotDepartment of Speech and Language Therapy Whiston Hospital Liverpool UK.
Narayanamoorthi SaravananHyperacute Stroke Unit Fairfield General Hospital, Northern Care Alliance NHS Trust Bury UK.
Marian C BradyResearch Centre for Health, Glasgow Caledonian University Glasgow UK.ORCID 0000-0002-4589-7021
Peter LanghorneSchool of Cardiovascular and Metabolic Health University of Glasgow Glasgow UK.ORCID 0000-0001-8185-2659
Giles I McCrackenSchool of Dental Sciences Newcastle University Newcastle UK.ORCID 0000-0003-1793-7417
Catherine E LightbodySchool of Nursing and Midwifery University of Central Lancashire Preston UK.ORCID 0000-0001-5016-3471
Caroline L WatkinsSchool of Nursing and Midwifery University of Central Lancashire Preston UK.ORCID 0000-0002-9403-3772
Paul R BrocklehurstPrimary Care Division Public Health Wales UK.ORCID 0000-0003-1878-9030

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundImproving oral health in patients with acutely dysphagic stroke is a plausible approach to prevent pneumonia. We aimed to determine whether a phase 3, definitive trial of oral health care (OHC) treatments, supported by staff education and training, is feasible in stroke unit care.

methodsThe CHOSEN (Chlorhexidine or Toothpaste, Manual or Powered Brushing to prevent Pneumonia Complicating Stroke) trial was conducted and reported in line with the Consolidated Standards of Reporting Trials 2010 statement extended to feasibility trials. We aimed to recruit 120 participants with acute stroke and dysphagia within 24 hours of admission, from 4 stroke units in the northwest of England, randomized (1:1:1:1) to 1 of 4 OHC treatments: manual toothbrush or powered toothbrush with either nonfoaming toothpaste or chlorhexidine 1% gel. Stroke unit nursing staff received standardized education and training. Feasibility was assessed using a priori criteria.

resultsBetween January 2022 and end of January 2023, 626 patients were screened. A total of 101 participants (median age, 73 [interquartile range, 62-80] years; median National Institutes of Health Stroke Scale score, 10 [interquartile range, 5-18]; 44% women) were enrolled (77% of eligible patients approached). Adherence was 91%, with no substantial difference between the OHC treatments, and 88% completed follow-up. There were 19 serious adverse events but no marked differences between allocated OHC treatments. In exploratory secondary analyses, again there were no substantial differences in survival, incident pneumonia, modified Rankin Scale score, or quality of life at 3 months between the OHC treatment allocations.

conclusionsOHC treatments incorporating chlorhexidine and powered brushing and supported by standardized staff training appeared feasible and safe in patients with acutely dysphagic stroke. Progression criteria were met for a definitive trial of efficacy and cost effectiveness. REGISTRATION: URL: https://doi.org/10.1186/ISRCTN52421361; Unique identifier: ISRCTN52421361.

Indexed as

ChlorhexidineDeglutition DisordersOral HealthOral HygienePneumonia, AspirationStrokeToothbrushingAgedAged, 80 and overEnglandFeasibility StudiesFemaleHumansMaleMiddle AgedTreatment OutcomeChlorhexidinechlorhexidineoral health carepoststroke pneumoniarandomized trialstroke, acute

Identifiers

PMID40932100
PMCPMC12554427

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.